Acutely ill children (n = 129) aged 1-6 years receiving antibiotic therapy were randomized to receive a nutritional supplement with (PS) or without (P) synbiotics or a fruit-flavored drink (D) with their medications. Group PS had significantly greater weight gains (versus D) following antibiotic therapy. The percentages of subjects without bacterial illnesses 14 days following antibiotic therapy were as follows: 94.3% (PS), 87.8% (D), and 80.6% (P). PS (vs D) significantly increased fecal Lactobacillus in a subset of subjects. Oral supplements increase energy intake and promote weight gain in acutely ill children receiving antibiotics; synbiotics may confer additional benefits by increasing bifidobacteria levels.

Children with acute otitis media (AOM), aged 2-12 years, were randomised to 10 days treatment with amoxycillin/clavulanate (A/C) 70/10 mg/kg/day given b.i.d. (231 patients) or to A/C 60/15 mg/kg/day given t.i.d. (232 patients). Clinical success rates at end of therapy (10-17 days) were 91.8% for the b.i.d. group and 90.5% for the t.i.d. group and at follow-up (28-42 days) were 80.1% for the b.i.d. group and 77.6% for the t.i.d. group, indicating that the b.i.d. regimen was as effective as the t.i.d. regimen. There was no statistically significant difference in incidence of adverse experiences between the two groups. The overall incidence of protocol defined diarrhoea assessed from diary booklets was low, with a lower incidence in the b.i.d. group (6.7%) than in the t.i.d. group (10.3%). Significantly more patients in the b.i.d. group (83.1%) than in the t.i.d. group (72.8%) had at least 80% compliance over a 7-10 day treatment period. A/C given twice or three-times daily was highly effective in the treatment of AOM in children. The two regimens showed equivalent clinical efficacy, both were well tolerated, and there was evidence of improved compliance with the b.i.d. regimen.